Cellares

Quality Control Raw Material Analyst

Bridgewater, NJ

Sponsorship not specified$90k-$210kDetected 13 days ago

SAPLogisticsERPGMPCommunication

About the role

Cell Shuttles will be deployed in Cellares' Smart Factories around the world to meet total patient demand for cell therapies at global scale.
Partnering with Cellares enables academics, biotechs, and pharma companies to accelerate drug development and scale out manufacturing, lower process failure rates, lower manufacturing costs, and meet global patient demand.
The company is headquartered in South San Francisco, California with its commercial-scale IDMO Smart Factory in Bridgewater, New Jersey.

Perform incoming inspection of raw materials, components, and single-use systems in accordance with approved sampling plans and acceptance criteria (e.g., AQL-based plans per ANSI/ASQ Z1.4)
Maintain sample shipping logs and ensure traceability from sample collection through receipt confirmation at the receiving lab
Perform compendial testing including but not limited to: pH (USP <791>), osmolality, conductivity, appearance/visual inspection (USP <790>), and FTIR (USP <854>)
Operate and maintain QC instruments
perform instrument calibration checks, cleaning, and basic troubleshooting in accordance with maintenance schedules
Operate and maintain QC instruments; perform instrument calibration checks, cleaning, and basic troubleshooting in accordance with maintenance schedules
Review and perform peer verification of raw material test results (CoA, external lab reports, in-house data) against approved specifications prior to disposition
Support change control activities, including assessment of changes to raw material specifications, sampling plans, or testing methods
Support internal audits and external regulatory inspections; assist with preparation of audit-ready documentation
The primary focus of this position is to support raw material incoming inspection, sampling, and compendial testing activities for cGMP manufacturing operations at Cellares' Smart Factory.

Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or a related science discipline required
Working knowledge of USP compendial methods relevant to raw material testing (e.g., <645>, <785>, <790>, <791>, <854>)
Proficiency in electronic QMS, ERP, and/or LIMS systems (e.g., Trackwise, SAP, LabVantage or equivalent)
ability to communicate effectively with cross-functional teams and external laboratory contacts

2+ years of hands-on experience in a cGMP pharmaceutical, biotech, or CDMO/IDMO environment, with direct experience in raw material or incoming quality control functions preferred
Familiarity with pharmacopeial standards and raw material qualification frameworks (USP, EP, ICH Q3C, ICH Q3D) is a plus
Experience with AQL-based sampling plans and statistical sampling methodologies preferred
Prior experience coordinating sample shipments to external CTOs, including documentation and cold-chain logistics, preferred

We are seeking a detail-oriented and operationally rigorous Quality Control Raw Material Analyst to join our Quality Control (QC) team in Bridgewater, New Jersey.

This listing is sourced directly from Cellares's careers page and normalized into a canonical job model.